Reference number
ISO 18113-1:2022
International Standard
ISO 18113-1:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
Edition 2
2022-10
Preview
ISO 18113-1:2022
79866
недоступно на русском языке
Опубликовано (Версия 2, 2022)

ISO 18113-1:2022

ISO 18113-1:2022
79866
Язык
Формат
CHF 194
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Тезис

This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.

This document does not address language requirements since that is the domain of national laws and regulations.

This document does not apply to:

a) IVD medical devices for performance evaluation (e.g. for investigational use only);

b) shipping documents;

c) material safety data sheets / Safety Data Sheets;

d) marketing information (consistent with applicable legal requirements).

.

Общая информация

  •  : Опубликовано
     : 2022-10
    : Опубликование международного стандарта [60.60]
  •  : 2
  • ISO/TC 212
    11.100.10 
  • RSS обновления

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